It's important to understand that all medications can potentially cause side effects. Some of these side effects are more harmful than others, and some medications are more likely to cause side effects than others. But even if a medication has the potential to cause a side effect, it doesn't mean that you will have that side effect if you take it. In most cases, a very small number of people actually experience a drug's potential side effect.
Still, the U.S. Food & Drug Administration (FDA) serves as a very cautious watchdog over the drugs that are made and sold in the United States. When studies show that a medication might cause a side effect, pharmaceutical companies have to own up to the possibility in all of the written materials that go with the medicine.
The good news is, asthma medications are quite safe overall. Most have very few side effects, and when you weigh their very significant benefits for your health and quality of life against any risks, it's usually no contest. However, a few asthma medications have been shown to cause some serious side effects, which has triggered the FDA to require what are called "black box warnings."
What Exactly Are Black Box Warnings?
When a drug is shown to have significant safety risks for those who take it, the FDA requires the pharmaceutical company to notify users through a special black-outlined box on the drug's packaging, prescribing information and/or package insert. Thus, the phrase, "black box warning."
A black box warning means that a drug presents potential safety risks, but those risks are not so great that the drug should be taken off the market. The FDA requires black box warnings to help both doctors and patients make more informed decisions about using the drug.
What Asthma Medications Have Black Box Warnings?
Black box warnings have been issued for a number of asthma medications:
- Xolair (omalzimub), an immune modulator given by injection
- Advair, a combination controller medication that contains both fluticasone and salmeterol
- Serevent Diskus (salmeterol), a long-acting beta agonist used as an asthma controller medication
- Foradil Aerolizer (formoterol), a long-acting beta agonist used as an asthma controller medication
- Symbicort, a combination controller medication that contains both budesonide and formoterol
Should I Stop Taking My Asthma Medication If It Has a Black Box Warning?
First of all, you should never stop taking any medication prescribed to you without talking to your physician first. Your asthma medication having a black box warning doesn't necessarily mean that you have to stop taking it. Inhaled steroids are the first-line treatment of choice for mild to moderate persistent asthma, and fortunately, there are no black box warnings for any of the inhaled steroids used with asthma. But inhaled steroids don't help all people with asthma, which is one of the reasons why there are so many other types of asthma medications available.
If you are one of the people who was not able to achieve adequate asthma control with an inhaled steroid, your doctor may have prescribed one of the other kinds of asthma medication, either instead of or in addition to the steroid. Most people do eventually get control over their asthma with this approach.
So, you and your doctor may need to weigh the benefits of taking one of the black box warning asthma medications against the risk of side effects. The final decision may depend on whether you actually have any side effects. If you don't, then you may be able to continue taking it, as long as you know the danger signs to be on alert for.
How High Is the Risk for Black Box Medications?
The Johns Hopkins Health Alerts newsletter reports that black box warnings for asthma medications came about in response to a long-term asthma study called the SMART study (for the Salmeterol Multi-center Asthma Research Trial), which compared the safety of salmeterol, a long-acting beta agonist (LABA), versus placebo.
The SMART study found that there were more asthma-related deaths among the people using salmeterol v. those using placebo. However, no other LABA was studied, nor were any of the combination asthma inhalers that pair an inhaled steroid with a LABA.
An analysis of 19 other studies by the Annals of Internal Medicine increased concern about this and related long-acting bronchodilators. The study revealed that medications like salmeterol and formoterol greatly increased:
- risk of hospitalization
- life-threatening exacerbations
- death
What is important to understand about these studies is that although the numbers of people having the serious side effects may have been "statistically significant," the actual number of people who had problems was relatively small.
What Should You Do?
If you are taking one of these black box warning asthma medications (or have had one prescribed), it's essential that you talk with your doctor about your concerns. Every treatment decision should be based on individual factors. People who have severe persistent asthma, in particular, often do very well on one of these medicines, especially when used in conjunction with an inhaled steroid.
If you are using a prescribed long-acting bronchodilator, such as Advair, Serevent, Foradil or Symbicort, and your wheezing gets worse and / or won't go away, let your doctor know immediately. It could be a sign that you need a change in medication. But don't just stop taking your medication on your own, or you may find that you have even more serious health problems as a result.
